Trial Outcomes & Findings for Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma (NCT NCT03484923)
NCT ID: NCT03484923
Last Updated: 2024-06-18
Results Overview
ORR defined as the percentage of patients with a best overall response of either confirmed complete response (CR) or partial response (PR) as per local review by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and assessed by computed tomography (CT)/ magnetic resonance imaging (MRI). CR:Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
COMPLETED
PHASE2
196 participants
Up to 49 months (randomized section) and 18 months (non-randomized section)
2024-06-18
Participant Flow
None of the arms were opened in the extension part.
The screening period began once written informed consent was provided and ended after 28 days (or after 35 days for subjects screened for Arm 1A) or when subject was randomized/enrolled, whichever came first. 1 participant randomized to Arm 3 discontinued before study treatment due to an AE.
Participant milestones
| Measure |
Arm 1: LAG525 + PDR001 (Randomized Section)
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 2: INC280+PDR001 (Randomized Section)
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 3: ACZ885 + PDR001 (Randomized Section)
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 4: LEE011 + PDR001 (Randomized Section)
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
45
|
43
|
43
|
44
|
21
|
|
Overall Study
Treated
|
45
|
43
|
42
|
44
|
21
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
45
|
43
|
43
|
44
|
21
|
Reasons for withdrawal
| Measure |
Arm 1: LAG525 + PDR001 (Randomized Section)
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 2: INC280+PDR001 (Randomized Section)
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 3: ACZ885 + PDR001 (Randomized Section)
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 4: LEE011 + PDR001 (Randomized Section)
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
5
|
11
|
1
|
|
Overall Study
Death
|
2
|
2
|
3
|
0
|
1
|
|
Overall Study
Physician Decision
|
6
|
7
|
6
|
3
|
2
|
|
Overall Study
Progressive disease
|
33
|
28
|
26
|
30
|
16
|
|
Overall Study
Subject Decision
|
1
|
3
|
3
|
0
|
1
|
Baseline Characteristics
Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Arm 1: LAG525 + PDR001 (Randomized Section)
n=45 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 2: INC280+PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 4: LEE011 + PDR001 (Randomized Section)
n=44 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
n=21 Participants
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Total
n=196 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
122 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
74 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
76 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
120 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
187 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to 49 months (randomized section) and 18 months (non-randomized section)Population: Randomized section: All participants to whom study treatment was assigned by randomization. Non-randomized section: All participants who received at least one dose of study treatment
ORR defined as the percentage of patients with a best overall response of either confirmed complete response (CR) or partial response (PR) as per local review by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and assessed by computed tomography (CT)/ magnetic resonance imaging (MRI). CR:Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Arm 1: LAG525 + PDR001 (Randomized Section)
n=45 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 2: INC280+PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 4: LEE011 + PDR001 (Randomized Section)
n=44 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
n=21 Participants
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
8.9 Percentage of participants
Interval 2.5 to 21.2
|
4.7 Percentage of participants
Interval 0.6 to 15.8
|
4.7 Percentage of participants
Interval 0.6 to 15.8
|
6.8 Percentage of participants
Interval 1.4 to 18.7
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
SECONDARY outcome
Timeframe: From first documented response to disease progression or death due to any cause, whichever occurs first, assessed up to 49 months (randomized part) and 18 months (non-randomized part)Population: Randomized section: All participants to whom study treatment was assigned by randomization for whom best overall response was complete response or partial response. Non-randomized section: All participants who received at least one dose of study treatment for whom best overall response was complete response or partial response
DOR defined as the time from date of first documented CR or PR to date of first documented disease progression (as per local review by RECIST v1.1 and assessed by CT/MRI) or death due to any cause. Subjects continuing without progression or death due to underlying cancer were censored at the date of their last adequate tumor assessment. CR:Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Arm 1: LAG525 + PDR001 (Randomized Section)
n=4 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 2: INC280+PDR001 (Randomized Section)
n=2 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=2 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 4: LEE011 + PDR001 (Randomized Section)
n=3 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
n=3 Participants
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
476 Days
Interval 169.0 to 1373.0
|
941.5 Days
Interval 504.0 to 1379.0
|
617.5 Days
Interval 113.0 to 1122.0
|
217 Days
Interval 169.0 to 281.0
|
281 Days
Interval 169.0 to 449.0
|
SECONDARY outcome
Timeframe: From randomization (or start of treatment for non-randomized section) to death due to any cause, assessed up to 49 months (randomized section) and 24 months (non-randomized section)Population: Randomized section: All participants to whom study treatment was assigned by randomization. Non-randomized section: All participants who received at least one dose of study treatment
OS was defined as the time from date of randomization (or date of first dose of study treatment in non-randomized part) to date of death due to any cause. The OS distribution was estimated using the Kaplan-Meier method, and the medians and 95% confidence intervals of the medians were presented.
Outcome measures
| Measure |
Arm 1: LAG525 + PDR001 (Randomized Section)
n=45 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 2: INC280+PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 4: LEE011 + PDR001 (Randomized Section)
n=44 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
n=21 Participants
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
|---|---|---|---|---|---|
|
Overall Survival (OS)
|
8.8 Months
Interval 6.3 to 21.4
|
12.1 Months
Interval 6.6 to 18.5
|
8.7 Months
Interval 5.7 to 17.9
|
10.1 Months
Interval 7.4 to 15.6
|
14.0 Months
Interval 8.4 to
NA: Not estimable due to the insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From randomization (or start of treatment for non-randomized section) to disease progression or death due to any cause, whichever occurs first, assessed up to 49 months (randomized section) and 18 months (non-randomized section)Population: Randomized section: All participants to whom study treatment was assigned by randomization. Non-randomized section: All participants who received at least one dose of study treatment
PFS was defined as the time between the date of randomization (or date of first dose of study treatment in non-randomized section) to the date of event defined as the first documented disease progression (as per local review by RECIST v1.1 and assessed by CT/MRI) or death due to any cause. If a subject had not had an event before leaving study or initiation of subsequent anticancer therapy, PFS was censored at the date of last adequate tumor assessment. The PFS distribution was estimated using the Kaplan-Meier method, medians and 95% confidence interval of the medians were presented.
Outcome measures
| Measure |
Arm 1: LAG525 + PDR001 (Randomized Section)
n=45 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 2: INC280+PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 4: LEE011 + PDR001 (Randomized Section)
n=44 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
n=21 Participants
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
2.7 Months
Interval 1.7 to 2.8
|
2.7 Months
Interval 2.4 to 2.8
|
2.7 Months
Interval 2.6 to 2.8
|
2.8 Months
Interval 2.7 to 4.4
|
2.8 Months
Interval 2.7 to 4.6
|
SECONDARY outcome
Timeframe: Up to 49 months (randomized section) and 18 months (non-randomized section)Population: Randomized section: All participants to whom study treatment was assigned by randomization. Non-randomized section: All participants who received at least one dose of study treatment
DCR was defined as the percentage of participants with best overall response of CR, PR or stable disease (SD) (as per local review by RECIST v1.1 and assessed by CT/MRI). CR:Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Outcome measures
| Measure |
Arm 1: LAG525 + PDR001 (Randomized Section)
n=45 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 2: INC280+PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 4: LEE011 + PDR001 (Randomized Section)
n=44 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
n=21 Participants
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
15.6 Percentage of participants
Interval 6.5 to 29.5
|
16.3 Percentage of participants
Interval 6.8 to 30.7
|
18.6 Percentage of participants
Interval 8.4 to 33.4
|
31.8 Percentage of participants
Interval 18.6 to 47.6
|
33.3 Percentage of participants
Interval 14.6 to 57.0
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Randomized section: Participants to whom study treatment was assigned by randomization with a determinant baseline immunogenicity sample for PDR001. Non-randomized section: Participants who received at least one dose of treatment with a determinant baseline immunogenicity sample for PDR001.
Percentage of participants who had a PDR001 ADA positive result at baseline.
Outcome measures
| Measure |
Arm 1: LAG525 + PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 2: INC280+PDR001 (Randomized Section)
n=38 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=40 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 4: LEE011 + PDR001 (Randomized Section)
n=41 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
n=20 Participants
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
|---|---|---|---|---|---|
|
Percentage of Participants With PDR001 Anti-drug Antibodies (ADA) Positive Result at Baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Randomized section: Participants randomized to Arm 1 with a determinant baseline immunogenicity sample for LAG525. Non-randomized section: Participants who received at least one dose of treatment with a determinant baseline immunogenicity sample for LAG525.
Percentage of participants who had a LAG525 ADA positive result at baseline. Only applicable for participants enrolled in Arm 1 and Arm 1A.
Outcome measures
| Measure |
Arm 1: LAG525 + PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 2: INC280+PDR001 (Randomized Section)
n=20 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 3: ACZ885 + PDR001 (Randomized Section)
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 4: LEE011 + PDR001 (Randomized Section)
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
|---|---|---|---|---|---|
|
Percentage of Participants With LAG525 Anti-drug Antibodies (ADA) Positive Result at Baseline
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Participants randomized to Arm 3 with a determinant baseline immunogenicity sample for ACZ885.
Percentage of participants who had an ACZ885 ADA positive result at baseline. Only applicable for subjects enrolled in Arm 3.
Outcome measures
| Measure |
Arm 1: LAG525 + PDR001 (Randomized Section)
n=39 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 2: INC280+PDR001 (Randomized Section)
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 3: ACZ885 + PDR001 (Randomized Section)
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 4: LEE011 + PDR001 (Randomized Section)
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
|---|---|---|---|---|---|
|
Percentage of Participants With ACZ885 Anti-drug Antibodies (ADA) Positive Result at Baseline
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion on Day 1 of Cycle 1, 2, 3, 4, 5, 6 and thereafter every 3 cycles until end of treatment (EOT), EOT, and 30 and 150 days post-EOT (assessed up to 49 months randomized section and 24 months non-randomized section). Cycle= 28 daysPopulation: Randomized section: Participants to whom study treatment was assigned by randomization with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample. Non-randomized section: Participants who received at least one dose of study treatment with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample.
Percentage of participants who tested positive for treatment-induced ADA for PDR001 (subjects with ADA-negative sample at baseline with at least one post-baseline ADA positive sample) as well as treatment-boosted ADA for PDR001 (subjects with baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment).
Outcome measures
| Measure |
Arm 1: LAG525 + PDR001 (Randomized Section)
n=40 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 2: INC280+PDR001 (Randomized Section)
n=34 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=38 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 4: LEE011 + PDR001 (Randomized Section)
n=39 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
n=19 Participants
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Were Treatment-induced ADA Positive and Treatment-boosted ADA Positive for PDR001
|
3 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-infusion on Day 1 of Cycle 1, 2, 3, 4, 5, 6 and thereafter every 3 cycles until end of treatment (EOT) and EOT (assessed up to 49 months in the randomized section and 18 months in the non-randomized section). Cycle= 28 daysPopulation: Randomized section: Participants randomized to Arm 1 with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample. Non-randomized section: Participants who received at least one dose of study treatment with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample.
Percentage of participants who tested positive for treatment-induced ADA for LAG525 (subjects with ADA-negative sample at baseline with at least one post-baseline ADA positive sample) as well as treatment-boosted ADA for LAG525 (subjects with baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment). Only applicable for subjects enrolled in Arm 1 and Arm 1A.
Outcome measures
| Measure |
Arm 1: LAG525 + PDR001 (Randomized Section)
n=40 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 2: INC280+PDR001 (Randomized Section)
n=19 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 3: ACZ885 + PDR001 (Randomized Section)
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 4: LEE011 + PDR001 (Randomized Section)
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Were Treatment-induced ADA Positive and Treatment-boosted ADA Positive for LAG525
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion on Day 1 of Cycle 1, 2, 3, 4, 5, 6 and thereafter every 3 cycles until end of treatment (EOT) and EOT (assessed up to 40 months). Cycle= 28 daysPopulation: Participants randomized to Arm 3 with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample.
Percentage of participants who tested positive for treatment-induced ADA for ACZ885 (subjects with ADA-negative sample at baseline with at least one post-baseline ADA positive sample) as well as treatment-boosted ADA for ACZ885 (subjects with baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment). Only applicable for subjects enrolled in Arm 3.
Outcome measures
| Measure |
Arm 1: LAG525 + PDR001 (Randomized Section)
n=38 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 2: INC280+PDR001 (Randomized Section)
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 3: ACZ885 + PDR001 (Randomized Section)
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 4: LEE011 + PDR001 (Randomized Section)
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Were Treatment-induced ADA Positive and Treatment-boosted ADA Positive for ACZ885
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and after 3-4 weeks of treatmentPopulation: Participants who received at least one dose of treatment with an evaluable baseline tumor biopsy sample and at least one evaluable post-baseline tumor biopsy sample with evaluable results for the three biomarker parameters.
Biomarker parameters included: 1) number of tumor infiltrating T cells (TIL), 2) activation level of TIL, and 3) changes in immune response gene expression signatures. For the number of TILs, an increase in tumoral CD8+ cell numbers compared to baseline was considered favorable. The activation level of TIL was assessed by the percentage of tumoral CD8+ cells expressing GzmB (a marker for cytotoxic activity) or Ki67 (a marker for cell proliferation), where an increase in either GZMB+/CD8+ or KI67+/CD8+ post-baseline was considered favorable. Changes in immune response gene expression signatures were evaluated by the levels in T-cell inflamed signature (TIS), where an increase from baseline was considered favorable. To be categorized as having a pFBP, a subject must meet the favorable criteria for at least two of the three biomarker parameters. The percentage of participants with pFBP was assessed.
Outcome measures
| Measure |
Arm 1: LAG525 + PDR001 (Randomized Section)
n=22 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 2: INC280+PDR001 (Randomized Section)
n=21 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=31 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 4: LEE011 + PDR001 (Randomized Section)
n=6 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
|---|---|---|---|---|---|
|
Percentage of Participants With a Favorable Biomarker Profile (pFBP)
|
13.6 Percentage of participants
Interval 2.9 to 34.9
|
4.8 Percentage of participants
Interval 0.1 to 23.8
|
6.5 Percentage of participants
Interval 0.8 to 21.4
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
—
|
POST_HOC outcome
Timeframe: Pre-treatment: up to 28/35 days (randomized/non-randomized). On-treatment: up to 49/19 months (randomized/non-randomized). Extended safety FU and Post-treatment survival FU: up to 49/24 months (randomized/non-randomized).Population: Randomized section: All participants to whom study treatment was assigned by randomization. Non-randomized section: All participants who received at least one dose of study treatment
Pre-treatment: deaths collected from day of patient's informed consent to the day before the first administration of study treatment. On-treatment: deaths collected from start of treatment to 30 days after last dose of study treatment. Extended safety follow-up: deaths collected from 31 days after last dose of study treatment up to 150 days after last dose of PDR001 (if this timepoint was later than 30 days after last dose of study treatment) Post-treatment survival follow-up: deaths collected from day 151 post-last dose of PDR001 or 31 days after last dose of study treatment (whichever occurred last) up to end of study.
Outcome measures
| Measure |
Arm 1: LAG525 + PDR001 (Randomized Section)
n=45 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 2: INC280+PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 4: LEE011 + PDR001 (Randomized Section)
n=44 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
n=21 Participants
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
|
|---|---|---|---|---|---|
|
All Collected Deaths
All deaths
|
37 Participants
|
33 Participants
|
33 Participants
|
33 Participants
|
12 Participants
|
|
All Collected Deaths
Pre-treatment deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
All Collected Deaths
On-treatment deaths
|
5 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
All Collected Deaths
Extended safety follow-up deaths
|
14 Participants
|
11 Participants
|
15 Participants
|
11 Participants
|
4 Participants
|
|
All Collected Deaths
Post-treatment survival follow-up deaths
|
18 Participants
|
19 Participants
|
15 Participants
|
19 Participants
|
7 Participants
|
Adverse Events
Arm 2: INC280+PDR001 (Randomized Part)- On-treatment Period
Arm 2: INC280+PDR001 (Randomized Part) - Extended Safety Follow-up
Arm 2: INC280+PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Arm 3: ACZ885 + PDR001 (Randomized Part)- On-treatment Period
Arm 3: ACZ885 + PDR001 (Randomized Part)- Extended Safety Follow-up
Arm 3: ACZ885 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Arm 4: LEE011 + PDR001 (Randomized Part)- On-treatment Period
Arm 4: LEE011 + PDR001 (Randomized Part)- Extended Safety Follow-up
Arm 4: LEE011 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Arm 1A: LAG525 + PDR001 (Non-randomized Part)- On-treatment Period
Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Extended Safety Follow-up
Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Post-treatment Survival Follow-up
Arm 1: LAG525 + PDR001 (Randomized Part)- On-treatment Period
Arm 1: LAG525 + PDR001 (Randomized Part)- Extended Safety Follow-up
Arm 1: LAG525 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Serious adverse events
| Measure |
Arm 2: INC280+PDR001 (Randomized Part)- On-treatment Period
n=43 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
|
Arm 2: INC280+PDR001 (Randomized Part) - Extended Safety Follow-up
n=43 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
|
Arm 2: INC280+PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
|
Arm 3: ACZ885 + PDR001 (Randomized Part)- On-treatment Period
n=42 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
|
Arm 3: ACZ885 + PDR001 (Randomized Part)- Extended Safety Follow-up
n=42 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
|
Arm 3: ACZ885 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
|
Arm 4: LEE011 + PDR001 (Randomized Part)- On-treatment Period
n=44 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
|
Arm 4: LEE011 + PDR001 (Randomized Part)- Extended Safety Follow-up
n=44 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
|
Arm 4: LEE011 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
|
Arm 1A: LAG525 + PDR001 (Non-randomized Part)- On-treatment Period
n=21 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
|
Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Extended Safety Follow-up
n=21 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
|
Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
|
Arm 1: LAG525 + PDR001 (Randomized Part)- On-treatment Period
n=45 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
|
Arm 1: LAG525 + PDR001 (Randomized Part)- Extended Safety Follow-up
n=45 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
|
Arm 1: LAG525 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Cardiac disorders
Atrial fibrillation
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Cardiac disorders
Myocarditis
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Endocrine disorders
Adrenal haematoma
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
General disorders
Asthenia
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
General disorders
Chest pain
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
General disorders
Fatigue
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
General disorders
General physical health deterioration
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Hepatobiliary disorders
Hepatitis
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
General disorders
Heteroplasia
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
General disorders
Oedema peripheral
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
General disorders
Pain
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
General disorders
Pyrexia
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Immune system disorders
Cytokine release syndrome
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Immune system disorders
Drug hypersensitivity
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Infections and infestations
Cellulitis
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Infections and infestations
Erysipelas
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Infections and infestations
Infection
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Infections and infestations
Pneumonia
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Infections and infestations
Sepsis
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Infections and infestations
Skin infection
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Injury, poisoning and procedural complications
Ocular procedural complication
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
General physical condition abnormal
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
Haemoglobin decreased
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
Liver function test abnormal
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
Liver function test increased
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spleen
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Nervous system disorders
Diabetic hyperglycaemic coma
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Nervous system disorders
Dizziness
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Nervous system disorders
Epilepsy
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Nervous system disorders
Headache
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Nervous system disorders
Hypoglossal nerve disorder
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Nervous system disorders
Peripheral nerve paresis
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Nervous system disorders
Seizure
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Product Issues
Device dislocation
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Vascular disorders
Hypotension
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Vascular disorders
Phlebitis
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Vascular disorders
Vena cava thrombosis
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Vascular disorders
Venous thrombosis
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
Other adverse events
| Measure |
Arm 2: INC280+PDR001 (Randomized Part)- On-treatment Period
n=43 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
|
Arm 2: INC280+PDR001 (Randomized Part) - Extended Safety Follow-up
n=43 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
|
Arm 2: INC280+PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
|
Arm 3: ACZ885 + PDR001 (Randomized Part)- On-treatment Period
n=42 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
|
Arm 3: ACZ885 + PDR001 (Randomized Part)- Extended Safety Follow-up
n=42 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
|
Arm 3: ACZ885 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
|
Arm 4: LEE011 + PDR001 (Randomized Part)- On-treatment Period
n=44 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
|
Arm 4: LEE011 + PDR001 (Randomized Part)- Extended Safety Follow-up
n=44 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
|
Arm 4: LEE011 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
|
Arm 1A: LAG525 + PDR001 (Non-randomized Part)- On-treatment Period
n=21 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
|
Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Extended Safety Follow-up
n=21 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
|
Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
|
Arm 1: LAG525 + PDR001 (Randomized Part)- On-treatment Period
n=45 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
|
Arm 1: LAG525 + PDR001 (Randomized Part)- Extended Safety Follow-up
n=45 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
|
Arm 1: LAG525 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.0%
6/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
14.3%
6/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
25.0%
11/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
14.3%
3/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
7.1%
3/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.1%
4/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
15.9%
7/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
45.5%
20/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Endocrine disorders
Hypothyroidism
|
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
3/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
11.9%
5/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
11.4%
5/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
11.1%
5/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Constipation
|
14.0%
6/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
16.7%
7/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
17.8%
8/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
23.3%
10/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
7.1%
3/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
20.5%
9/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
23.8%
5/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
13.3%
6/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Dry mouth
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.5%
4/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Nausea
|
41.9%
18/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
21.4%
9/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
34.1%
15/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
28.6%
6/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
28.9%
13/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Gastrointestinal disorders
Vomiting
|
25.6%
11/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
7.1%
3/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
18.2%
8/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
14.3%
3/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
13.3%
6/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
General disorders
Asthenia
|
16.3%
7/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
16.7%
7/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
18.2%
8/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
33.3%
7/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
20.0%
9/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
General disorders
Chest pain
|
7.0%
3/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
General disorders
Chills
|
7.0%
3/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
General disorders
Fatigue
|
11.6%
5/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
11.9%
5/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
18.2%
8/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
19.0%
4/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
15.6%
7/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
General disorders
Oedema peripheral
|
23.3%
10/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
General disorders
Pain
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
8.9%
4/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
General disorders
Pyrexia
|
30.2%
13/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
18.2%
8/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Infections and infestations
Rhinitis
|
7.0%
3/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
Alanine aminotransferase increased
|
14.0%
6/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
34.1%
15/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
Amylase increased
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
7.1%
3/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
11.6%
5/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
7.1%
3/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
38.6%
17/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
Blood alkaline phosphatase increased
|
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
8.9%
4/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
Blood creatinine increased
|
11.6%
5/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.1%
4/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
Blood potassium decreased
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
Haemoglobin decreased
|
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
Lipase increased
|
7.0%
3/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
7.1%
3/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
11.4%
5/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
Neutrophil count decreased
|
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
Platelet count decreased
|
7.0%
3/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
SARS-CoV-2 test negative
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.1%
4/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
Weight decreased
|
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
11.9%
5/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.1%
4/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
13.3%
6/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Investigations
White blood cell count decreased
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.1%
4/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.0%
3/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
16.7%
7/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
20.5%
9/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
22.2%
10/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.0%
3/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
11.1%
5/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.3%
4/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
13.6%
6/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
11.1%
5/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.0%
3/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
11.1%
5/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Nervous system disorders
Dizziness
|
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Nervous system disorders
Headache
|
11.6%
5/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.1%
4/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Nervous system disorders
Paraesthesia
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.1%
4/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.6%
8/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
18.2%
8/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.0%
6/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
19.0%
8/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.1%
4/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.0%
6/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
7.1%
3/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
18.2%
8/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
14.3%
3/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
24.4%
11/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.6%
8/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
7.1%
3/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.1%
4/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
8.9%
4/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
8.9%
4/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
|
Vascular disorders
Hypertension
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
—
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER